COPYRIGHT 2009 BioMed Central Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights or concerns about this content should be directed to Customer Service.

Trials of new palliative care services are rare and beset with serious methodological problems, in some instances so severe that the studies fail [1]. Systematic reviews have attempted to assess the effectiveness of palliative home care [2], multidisciplinary teams [3, 4], day care [5], support for carers [6], services for older people [7] and in dementia [8]. They identified: (1) a wealth of studies concerned with need rather than treatment, and (2) problems of trial compliance, recruitment, attrition, contamination, bias, outcome measurement and definition of the intervention.

This has led some to question whether randomised controlled trials are appropriate in palliative care [1, 8]. In addition, ethical concerns have been raised about randomising patients who may be near the end of life [9]. However, non-randomised and quasi-experimental studies suffered from similar problems to those found in trials [4, 5, 6]. Robust evaluation and trial methods are urgently needed. Modelled on clinical trials, with phase I, II and III studies, the MRC framework for the evaluation of complex interventions has recently provided a useful model for developing and evaluating services or other complex treatments [10, 11]. The recommendation for palliative care to expand to encompass non-cancer patients and cancer patients earlier in their illness urgently needs evaluation. New methods are required to test services in this context.

Multiple sclerosis (MS) is one condition where palliative care is felt to be needed. This chronic disease of the central nervous system affects over 2.5 million people worldwide and is the most common cause of neurological disability in adults under 60 years [12]. As the disease affects many parts of the central nervous system it may be accompanied by marked physical and psychosocial symptoms. In a small proportion of patients the disease may result in profound disability leading to a need for the provision of complex care and, for some people, information on planning around end of life care. Although for many the prognosis is good, around 15% of those affected have primary progressive disease from the outset and a further 35% develop a progressive course after many years of relapsing illness. Thus palliative care may have a role for patients with complex problems, particularly for those with progressive disease.

We designed and sought to determine whether a new palliative care service for people severely affected by MS improves their outcomes. However, because poor recruitment, attrition and missing data are commonly high in palliative care studies [2, 3, 4] we wished to test a design not previously used in palliative care - a fast track (also called wait list) trial. This analysis aimed to assess the results of recruitment, compliance, and follow-up of this trial design in this complex group of patients. The design sought to minimise missing data for any reason; and when it was present to understand its patterns and influencing factors. Therefore, we tested the following null hypotheses: 1) missing data would not be associated with patient disability; 2) missing data would not be associated with particular measurement instruments. We explored whether missing data was associated with any other patient, outcome or study characteristics, to inform future imputations. We believe that lessons from our recruitment and trial compliance will add to knowledge in the field and further the development and application of appropriate research in palliative care.

Methods

Design, Project Advisory Committee, Ethical (IRB) approval

We followed the Medical Research Council (MRC) Framework for the Evaluation of Complex Interventions [10, 11]. This follows a similar framework to that of clinical trials and comprises 5 phases: pre-clinical (theory) and phases I (service modelling), II (preliminary evaluation of service), III (full randomised controlled trial), IV (wide adoption and effectiveness studies). We have previously reported the pre-clinical and phase I findings, which comprised qualitative studies [13, 14, 15] and systematic literature reviews [16]. Here we report phase II - an open randomised controlled trial to test subsequent evaluation methods and a preliminary comparison of the new service with standard best practice. Figure 1 uses a graphical method [17] to depict the interventions, interviews and timings in the trial.

Although not all phase II MRC Framework studies comprise a randomised trial, we wished to do so because: (1) to begin to operate the service without a trial would make it very difficult to introduce a trial subsequently, and might lead to ethical concerns among staff because of an 'apparent' reduction in service, making a phase III trial impossible, and (2) we felt it important to test the subsequent trial methods. However, we chose to conduct a fast-track versus standard care intervention trial (also called a wait list trial) because we were concerned about contamination and poor uptake in the control group - a problem found in many other randomised controlled trials of palliative care services [3, 4]. In the fast track (wait list) design all patients have the possibility to receive the service, some immediately, and others after a wait (equivalent to a normal wait for NHS services). The detailed protocol is presented elsewhere [13] (registered at clinicaltrials.gov, NCT00364936). A multidisciplinary Project Advisory Committee (PAC) was established for the duration of the project. Research ethics committee approval from King's College Hospital local research ethics committee was granted for all phases of the project.

Patients and carers

Inclusion criteria were: Patients in South East London who were living with MS and were deemed (by staff - MS nurses, neurologists, rehabilitation staff, primary care staff, social workers - and in a few instances via voluntary groups and self referrals) - to have specialist palliative care needs. These referral guidelines were circulated in advance and explained in an accompanying education programme and were defined as problems or unresolved issues with: symptom control, psychosocial needs, end of life, advanced planning (directive and competency or consent), planning needs for or difficulty with nutrition and/or hydration or a complex combination of problems. A consultant in palliative medicine (PE or IJH) not involved in delivering the service screened all referrals. Patients were excluded if the referring staff and the screening deemed they had very urgent needs or were deteriorating rapidly. In this instance immediate referral to the service was offered, and the patient was withdrawn from the trial (required for 5/69 patients). Clinical information was recorded where possible on those excluded from the evaluation to allow further understanding of clinical issues [13].

Randomisation

Consenting patients were randomised after the baseline interview to two arms. One arm received input from the palliative care team immediately (fast track) in addition to standard best practice services. The other arm was offered the palliative care team only after a > 3 month wait, and until then received only best practice (standard best practice) (Figure 1). Statistical colleagues, independent of the research and clinical team, registered the patients, conducted the randomisation and informed the research team, who then informed the patients, and if patients were "fast track" passed their details to the clinical team. The randomisation used the minimisation method [18] to give an equal balance between groups of the following: gender, age, date of diagnosis, and whether patients could or could not communicate. …

IntroductionConducting high-quality research in the palliative and end-of-life care setting is challenging1,2 and there is an absence of evidence for pharmaceutical interventions in this context. In 2006, with funding from the Australian Government, the Australian Palliative Care Clinical Studies…

Abstract Background: Palliative care has been proposed to help meet the needs of patients who suffer progressive non-cancer conditions but there have been few evaluations of service development initiatives. We report here a novel protocol for the evaluation of a new palliative care service in this…

IntroductionHomelessness is associated with multiple health problems and premature death, and there is growing understanding that long-term homelessness is a health issue. 1-3 Inadequate care for homeless people leads to increased expenditure, with a minority of homeless people making frequent use…